Device product
Y-Type Blood Set, Catalog Number 490530
Z-0939-2020
Product summary
- Event
- Event 84365
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9,000 units
- Official record key
device-enforcement:Z-0939-2020
Official wording
Reason: Potential for leakage at the joint between the blood filters and tubing
Code information: GUIDID: 04046955203321 Lot Numbers: 61674878 - Expiration Date: April 30, 2022, 61677192 - Expiration Date: April 30, 2022, 61678186 - Expiration Date: April 30, 2022, 61681736 - Expiration Date: May 31, 2022, 61685105 - Expiration Date: June 30, 2022
Distribution pattern: US Nationwide
Derived failure modes
-
Unknown
Potential for leakage at the joint between the blood filters and tubing